North Maharashtra University, Jalgaon 
                                      
                                      
                                      
                                                  
                                      
                                      
                                      
                                      
                               Syllabus of 
                                      
               Final Year B. Pharmacy (Sem VII & Sem VIII) 
                                      
                                      
                                      
                                      
                     W.E.F. Academic Year 2015-2016 
                                                                      
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                             T- 4.7.1 Pharmaceutical Technology II (Pharmaceutics –VIII) 
                                                              (Theory)(3Hrs/week) 
                                                                            
             Sr.                                                   Topics                                                     Hrs. 
             No.                                                                                                                  
                                                                  Section- I                                                      
              1.    Parenteral Preparations:                                                                                   12 
                    A} General requirements: -  
                    Concept of sterile products. Definition and Introduction of Parenteral Preparation. 
                    Historical      background,        Ideal     Requirements,        Advantages,        Disadvantages, 
                    Classification,  Precautions,  Brief  discussion  on  preformulation  factors  for 
                    parenterals. Routes of Administration {Primary and Secondary}, Water for Injection 
                    (WFI)  and  its  preparation  methods,  Sterile  Water  for  Injection  (SWFI),  and 
                    Bacteriostatic Water for Injection (BWFI), Pharmacopoeial evaluation of SWFI and 
                    WFI. Non aqueous solvents used in parenteral formulations. Pyroginicity, sources & 
                    removal of pyrogens. Isotonicity. Formulation additives for Parenterals. Preparation 
                    of  sterile  powders  {Liophilization}.  Long  acting  parenteral  formulations  such  as 
                    suspensions, emulsions, and depot preparations. Effect of route of administration. 
                    B} Packing of Parenterals: -  
                    Containers- Glass- Introduction, advantages and disadvantages, composition of glass. 
                    Types of glass. Problems encountered with glass containers such as leaching and 
                    flaking. Evaluation of glass containers {Powdered glass test, Water attack test and 
                    light  transmission  test  for  colored  glass}.  Containers-  Plastic-  Introduction, 
                    advantages  and  disadvantages,  classification  of  plastics  {thermoplastic  and 
                    thermosetting type- brief explanation} evaluation of plastic containers for parenteral 
                    preparations. Closures- Rubber- Introduction, excipients or additives used in rubber 
                    closures,  Ideal  characteristics  of  rubber,  types  of  rubbers.  Evaluation  of  rubber 
                    closures. Aseptic packaging via Form Fill Seal Technology. Sealing of Ampoules. 
                    C} Design of facilities and environmental control: -  
                    Basic design, environmental control, class 100 and other areas. HEPA filters, HVAC 
                    system. Laminar Flow Rooms {Horizontal & Vertical}. Validation of Environment. 
                    Validation  of  HEPA  filters  {Hot  &  Cold  DOP  test}.  Concept  of  CIP  {Clean  in 
                    Place} & SIP {Steam in Place}. 
                    D} Personnel factors: -  
                    Contamination in pharmaceutical parenteral plant, selection of clean room personnel, 
                    training programs for clean room employees, motivation of employees. 
                    E} Processing of Parenteral Products: -  
                    Processing  of  parenteral  products  by  terminal  sterilization,  filtration  sterilization. 
                    Validation of sterilization equipments, Biological & Chemical Indicators. 
                    F} Quality control and Quality Assurance of Parenterals: -  
                    Evaluation  of  Parenteral  Products  by  Pyrogen  test,  Clarity  test,  Leaker  test  and 
                    sterility test. 
              2.    Ophthalmic Products:                                                                                       05               
                    Definition, Introduction, Types of Ophthalmic Products. Anatomy and Physiology of                                          e2
                    the  eye.  General  requirement  /  safety  consideration.  Formulation,  isotonicity                                      Pag
                    
                    adjustment. Sodium chloride equivalent method {Calculation of dissociation factor 
                    and sodium chloride equivalent}. Problems on Isotonicity calculation. Sterilization of 
                    ophthalmic  products  {Steam  sterilization,  filtration,  gaseous  and  radiation}. 
                    Composition  of  Tears,  Artificial  Tears.  Mechanism  of  ocular  drug  absorption 
                    {Corneal & Non corneal}. Glaucoma and its management. Packing of eye drops. 
                    Evaluation of ophthalmic products.  
              3.    Drug Stability: -                                                                                          06 
                    Introduction, Definition of stability, Concept of expiry date or shelf life, Reasons for 
                    stability, Advantages. Kinetic studies versus stability studies. Physical degradation of 
                    Pharmaceutical Products with their preventive measures. Chemical decomposition of 
                    drugs  with  their  preventive  measures  such  as  –  Hydrolysis  {Ester  and  amide 
                    hydrolysis with examples}, Oxidation {Auto oxidation kinetics of ascorbic acid}. 
                    Miscellaneous reactions with their preventive measures such as optical isomerisation, 
                    epimerization,  geometrical  isomerisation,  polymerization,  and  decarboxylation. 
                    Effect  of  light  {Photochemical  decomposition},  pH,  and  temperature  on  drug 
                    decomposition. Brief introduction to ICH guidelines for stability testing. 
                                                                 Section- II                                                      
             4.     Oral sustained and controlled drug delivery system:                                                       07 
                    Definition,  Introduction,  rationale,  advantages,  and  disadvantages.  Comparison  of 
                    sustained  and  controlled  drug  delivery  system.  Model  drug  selection  criteria  for 
                    sustained and controlled drug delivery system. Classification – details of matrix and 
                    diffusion control systems. Biopharmaceutical aspects –concept of maintenance dose 
                    & loading dose. Evaluation of SR & CR Tablets only. 
             5.     Polymers used sustained and controlled drug delivery system:                                              04 
                    Brief  introduction  to  polymers,  linear  polymers,  branched  polymers,  cross  linked 
                    polymers, classification of polymers based on method of polymerization, properties 
                    of polymers, characterization of polymers. Examples of polymers such as celluloses, 
                    chitosan, Polylactide – coglycolide {PLGA}. 
             6.     Microencapsulation:                                                                                       07 
                    Definition, Introduction, Typical shapes of Microcapsules, Types of microcapsules, 
                    importance  of  microcapsulation  in  pharmacy,  Core  and  Coating  materials, 
                    Formulation  of  microcapsules  by  coacervation  phase  separation,  air  suspension 
                    technique,  multiorifice  centrifugal  process,  solvent  evaporation,  spray  drying  and 
                    spray  congealing,  pan  coating.  Introduction  of  a  relatively  new  technique 
                    “Polymerization,”.  Brief  discussion  on  magnetic  microspheres,  evaluation  of 
                    microcapsules. 
             7.     Optimization:                                                                                             04 
                    Definition, Introduction, Optimization parameters – Problem type {Constrained & 
                    Unconstrained} and Variable type {Independent and Dependent Variables}, surface 
                    response,  Classical  optimization.  Statistical  design  and  optimization  methods. 
                    Applications of optimization in Pharmacy. 
                                                                                                              Total Hours: 45 
                                             
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                       P - 4.7.1 Pharmaceutical Technology II (Pharmaceutics –VIII)  
                                                 (Practical) (3Hrs/week) 
                                                              
               Note: Conduct any 15 experiments from following list. A) Products may be assayed to 
               evaluate  accuracy  in  regular  practical.  Assays  are  not  to  be  given  to  students  in 
               University examinations. 
                
               B)  Formulation  of  different  dosage  forms  should  give  stress  on  raw  material 
               specifications, preformulation, process controls, and documentation. 
               1)  Introduction to Parenterals. 
               2)  To prepare & evaluate ampoule containing SWFI. 
               3)  To prepare & evaluate ampoule containing ascorbic acid injection. 
               4)  To prepare & evaluate ampoule containing calcium gluconate injection. 
               5)  To prepare & evaluate sodium chloride and dextrose injection. 
               6)  To prepare & evaluate ampoule containing atropine sulphate injection. 
               7)  To prepare & evaluate ampoule containing sodium thiosulphate injection. 
               8)  Introduction to Ophthalmic Products. 
               9)  To prepare & evaluate zinc sulphate eye drop. 
               10) To prepare & evaluate sulphacetamide sodium eye drop. 
               11) To prepare & evaluate chloramphenicol eye ointment.  
               12) To prepare & evaluate sulphacetamide sodium eye ointment. 
               13) To perform powdered glass test. 
               14) To perform water attack test. 
               15) To evaluate plastic containers used for parenteral products. 
               16) To evaluate rubber closures used for glass containers containing parenteral products. 
               17) Accelerated stability testing of an injection. 
               18) Preparation and evaluation of microspheres. 
               19) Formulation and evaluation of one controlled release/sustained release formulation. 
                
               Book Recommended for Theory & Practical’s:-  
               1.  Leon Lachman. The Theory and Practice of Industrial Pharmacy. Third edition. Varghese 
                   publication. 
               2.  Ansel-- P’ceutical dosage forms and drug delivery system. Eight edition.Indian edition by 
                   B. I. publications. 
               3.  Alfanso R. Gennaro-- Remington’s Pharmaceutical Sciences. 21st Edition, Vol. I & II. 
               4.  Rawling-- Bentleys T.B. of Pharmaceutics. 
               5.  Lockhart-- Packaging of Pharmaceuticals and healthcare products 
               6.  D A Dean, E R Evans --Pharmaceutical Packaging Technology 
               7.  Swarbrick & Boyan -- Encyclopedia of Pharm. Tech. 
               8.  Banker & Rhodes-- Modern pharmaceutics. 
               9.  S J Turco-- Sterile dosage forms  
               10. Liberman H. A. and Leon Lachman. Pharmaceutical dosage forms: - Parenteral 
                   Medications. Vol. 1, 2 and 3. Second edition, Marcel Dekker. 
               11. C. V. S. Subrahmanyam. Text Book of Physical Pharmaceutics. Second edition, Vallabh 
                   prakashan.  
               12. B. M. Mithal. A text book of Pharmaceutical Formulation. Sixth edition, Vallabh 
                   prakashan.  
               13. Official Books such as I.P., B.P., B.P.C., U.S.P. 
               14. Niazi. Handbook of Pharmaceutical manufacturing formulations. (Vol. 1-6) 
               15. Deasy. Microencapsulation and related drug processes.                                             
               16. E.A. Rawlin. Bentley’s textbooks of Pharmaceutics. Eighth edition. Elsevier publication.         e4
               17. Michael E. Aulton. Aulton’s Pharmaceutics. The design and manufacture of medicines. 
                   Third edition. Elsevier publication.                                                             Pag